Manager- Quality OSD Value Stream

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Detailed Job Description

• Overall Responsibility
  
  

To ensure end-to-end Quality Assurance oversight across pharmaceutical manufacturing sites, act as Qualified Person (QP) for batch certification and release, and lead product lifecycle management activities in compliance with cGMP, regulatory requirements, and company quality standards.

• cGMP Compliance
  
  

To ensure cGMP compliance in the related pharmaceutical manufacturing plants by monitoring:

• Good Documentation Practices.
• Correctness of batch documents, logbooks, labels, etc.
• Gowning attire.
• Cleanliness.
• Compliance with environmental conditions of all classified areas.
• Ensuring all equipment is used in a calibrated and qualified state.
• Adherence to SOPs, manufacturing and packaging instructions.
• All end-to-end activities in the manufacturing plants.
• Deviations & Investigations
  
  

Review and approve manufacturing operations-related deviation investigations and product quality-related investigations, including:

• Deviations
• Complaints
• Recalls
  
  

Ensure timely completion of investigations and assessments in Ample Logic.

• CAPA
  
  

Review and approve CAPA for related plants in Ample Logic and ensure proper implementation.

• Change Control
  
  

Review and approve change controls and related assessments for products/plants in Ample Logic.

• Site Inspections
• Perform regular site inspections.
• Monitor self-inspections.
• Monitor GMP inspection CAPA compliance.
• Quality Improvement & Quality Culture
• Responsible for implementing the Quality Improvement Plan at the respective site.
• Coordinate with cross-functional teams (CFTs) to establish and spread the Quality Culture.
• Batch Documentation
  
  

Approve

• BMR – Batch Manufacturing Record
• BPR – Batch Packaging Record
• Product Lifecycle Management Responsibilities
  
  

Lead QA Oversight Across The Entire Product Lifecycle, Including

• Technology Transfer
• Process Validation (PPQ)
• Commercial Manufacturing
• Continued Process Verification (CPV)
• Product Discontinuation
  
  

Ensure Effective Execution And Review Of

• APQR / PQR trends
• Ongoing stability programs
• Lifecycle risk assessments
• Continuous improvement initiatives based on lifecycle data
• Technical & GMP Documentation
  
  

Review all technical department SOPs for adequacy of procedure contents, risk assessments, and other GMP documents from a quality perspective.

• People Development & Batch Document Audit
• Identify, develop, and train successors for the role, if needed.
• Coach others in the area of expertise.
• Ensure other functions, such as Operations, have sufficient product knowledge and understanding to execute their roles.
• Lead batch document audits.
• Lead retention sample checking.
• Ensure timely and compliant execution as per approved procedures.
• Shipment Checks
  
  

Supervise final checks of shipments before dispatch, ensuring all procedures are followed, including approvals of shipments under quarantine as per Sales/Tender department requirements.

• Training
  
  

Develop and deliver training programs to enhance team capabilities and knowledge of:

• Batch release
• Documentation
• Compliance standards
• Audit Readiness
  
  

Ensure all batch release documentation and processes are audit-ready for both internal and external audits.

• Usage Decision
  
  

Make the final Usage Decision (UD) following a thorough review of the complete batch documentation.

• Compliance Communication
  
  

Act as the primary contact for compliance-related communications, addressing discrepancies and collaborating with cross-functional teams.

• Batch Compliance Issues
  
  

Proactively address batch-related compliance issues and provide solutions to prevent recurrence.

• Compliance & Batch Release Goals
  
  

Focus on achieving compliance and batch release goals with strong ownership and accountability.

• QA Operations KPIs
  
  

Responsible for QA Operations KPI adherence and timely reporting for the respective site.

• Batch Release Priorities
  
  

Effectively manage multiple batch release priorities in a fast-paced and dynamic environment.

• Qualification & Validation
  
  

Review qualification and validation documents, including protocols and reports, such as:

• Facility Qualification
• Equipment Qualification
• Process Validation
• Cleaning Validation
• Facility & Utility Layouts
  
  

Review facility and utility layouts for related plants.

• Line Clearance / Line Release
  
  

Ensure Compliance With SOP Requirements For

• Line Clearance
• Line Release
• In-Process Quality & Team Training
• Impart continuous training to the QA Operations team on Quality and cGMP systems.
• Ensure compliance with in-process quality check activities according to SOPs in production and packaging departments.
• Ensure compliance with cGMP principles.
• Ensure test results are properly captured in batch records.
• Health, Safety & Environment
  
  

Maintain a safe and healthy work environment by following standards and procedures and complying with applicable regulations.

• Other Responsibilities
  
  

Perform any other responsibilities assigned by the Quality Assurance Senior Manager / Director.

Core Competency

• High focus on process compliance.
• Responsible approach.
• High accountability and ownership.
• Excellent team-building skills.
• Strong time and task management.
• Excellent oral and written communication skills in English.
• Highly disciplined.
• Motivated and organized.
• Ensure team adherence to EMS and HSE requirements through monitoring, training, and guidance.
• Lead incident investigations and root cause analysis.
• Lead implementation of corrective/preventive actions.
• Drive departmental initiatives for environmental performance improvement and HSE culture.
  
  

Qualification / Functional Knowledge

• Bachelor of Pharmacy.
• Minimum 10+ years of experience in Quality Assurance oversight of Oral Solid Dosage (OSD) manufacturing operations.
• Batch release experience.
• Product Lifecycle Management experience.
• Good experience with QMS systems.
• Good knowledge and command of cGXP.
• Knowledge of Risk Assessment.
  
  

We value people from different backgrounds. Could this be your story Apply today or visit www.Julphar.net to read more about us and the journey of Julphar